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Tessalon (benzonatate)
Benzonatate (Tessalon Perles) is a non-narcotic prescription antitussive that works by anesthetizing pulmonary stretch receptors. Approved in 1958. Capsules must be swallowed whole (choking risk if chewed). Available generically.
At a glance
| Generic name | benzonatate |
|---|---|
| Also known as | Tessalon, Tessalon Perles |
| Sponsor | Generic (originally Pfizer) |
| Drug class | Non-narcotic Antitussive [EPC] |
| Target | Sodium channel protein type 5 subunit alpha |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 1958-01-01 (United States) |
Approved indications
- Cough
Common side effects
- Sedation
- Headache
- Dizziness
- Constipation
- Nausea
- GI upset
- Pruritus
- Skin eruptions
- Nasal congestion
- Sensation of burning in the eyes
- Vague chilly sensation
- Numbness of the chest
Serious adverse events
- Bronchospasm
- Laryngospasm
- Cardiovascular collapse
- Hypersensitivity reactions
- Death from overdose
Key clinical trials
- Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers (Phase 1)
- A Multicentric Randomized Double-blind Placebo-controlled Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms (Phase 3)
- The Single-dose and Multiple-dose Pharmacokinetic Study of Benzonatate Soft Capsule in Chinese Healthy Subjects (Phase 1)
- A Phase I, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Tolerability of Benzonatate Following Single Dose Administration in Healthy Volunteers (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tessalon CI brief — competitive landscape report
- Tessalon updates RSS · CI watch RSS
- Generic (originally Pfizer) portfolio CI